DOSAGE AND ADMINISTRATION
Dosage and route of administration should be determined
by susceptibility of the causative organisms, severity of the infection, and
the condition of the patient (see table for dosage guideline). CLAFORAN
may be administered IM or IV after reconstitution. Premixed CLAFORAN Injection
is intended for IV administration after thawing. The maximum daily dosage
should not exceed 12 grams.
GUIDELINES FOR DOSAGE OF CLAFORAN
|Type of Infection
||Daily Dose (grams)
||Frequency and Route
|Gonococcal urethritis/ cervicitis in males and females
||0.5 gram IM (single dose)
|Rectal gonorrhea in females
||0.5 gram IM (single dose)
|Rectal gonorrhea in males
||1 gram IM (single dose)
||1 gram every 12 hours IM or IV
|Moderate to severe infections
||1-2 grams every 8 hours IM or IV
|Infections commonly needing antibiotics in higher dosage (e.g., septicemia)
||2 grams every 6-8 hours IV
||up to 12
||2 grams every 4 hours IV
If C. trachomatis is a suspected pathogen,
appropriate anti-chlamydial coverage should be added, because cefotaxime sodium
has no activity against this organism.
To prevent postoperative
infection in contaminated or potentially contaminated surgery, the recommended
dose is a single 1 gram IM or IV administered 30 to 90 minutes prior to start
Cesarean Section Patients
The first dose of 1 gram is administered intravenously as
soon as the umbilical cord is clamped. The second and third doses should be
given as 1 gram intravenously or intramuscularly at 6 and 12 hours after the
Neonates, Infants, and Children
The following dosage schedule is recommended:
Neonates (birth to 1 month):
0-1 week of age - 50 mg/kg per dose every 12 hours IV
1-4 weeks of age - 50 mg/kg per dose every 8 hours IV
It is not necessary to differentiate between premature
and normal-gestational age infants.
Infants and Children (1 month to 12 years):
For body weights less than 50 kg, the recommended daily
dose is 50 to 180 mg/kg IM or IV body weight divided into four to six equal
doses. The higher dosages should be used for more severe or serious infections,
including meningitis. For body weights 50 kg or more, the usual adult dosage
should be used; the maximum daily dosage should not exceed 12 grams.
This drug is known to be substantially excreted by the
kidney, and the risk of toxic reactions to this drug may be greater in patients
with impaired renal function. Because elderly patients are more likely to have
decreased renal function, care should be taken in dose selection, and it may be
useful to monitor renal function. (See PRECAUTIONS, General and PRECAUTIONS,
Impaired Renal Function
see PRECAUTIONS, General. NOTE: As with
antibiotic therapy in general, administration of CLAFORAN should be continued
for a minimum of 48 to 72 hours after the patient defervesces or after evidence
of bacterial eradication has been obtained; a minimum of 10 days of treatment
is recommended for infections caused by Group A beta-hemolytic streptococci in
order to guard against the risk of rheumatic fever or glomerulonephritis;
frequent bacteriologic and clinical appraisal is necessary during therapy of
chronic urinary tract infection and may be required for several months after
therapy has been completed; persistent infections may require treatment of
several weeks and doses smaller than those indicated above should not be used.
Preparation of CLAFORAN Sterile
CLAFORAN for IM or IV administration should be
reconstituted as follows:
||Withdrawable Volume (mL)
||Approximate Concentration (mg/mL)
|500 mg vial* (IM)
|1g vial* (IM)
|2g vial* (IM)
|500 mg vial* (IV)
|1g vial* (IV)
|2g vial* (IV)
|(*) in conventional vials
Shake to dissolve; inspect for
particulate matter and discoloration prior to use. Solutions of CLAFORAN range
from very pale yellow to light amber, depending on concentration, diluent used,
and length and condition of storage.
For intramuscular use: Reconstitute VIALS with
Sterile Water for Injection or Bacteriostatic Water for Injection as described
For intravenous use: Reconstitute VIALS with
at least 10 mL of Sterile Water for Injection. Reconstitute INFUSION BOTTLES
with 50 or 100 mL of 0.9% Sodium Chloride Injection or 5% Dextrose Injection.
For other diluents, see Compatibility And Stability section.
NOTE: Solutions of CLAFORAN
must not be admixed with aminoglycoside solutions. If CLAFORAN and
aminoglycosides are to be administered to the same patient, they must be
administered separately and not as mixed injection.
A SOLUTION OF 1 G CLAFORAN IN
14 ML OF STERILE WATER FOR INJECTION IS ISOTONIC.
IM Administration: As with all IM
preparations, CLAFORAN should be injected well within the body of a relatively
large muscle such as the upper outer quadrant of the buttock (i.e., gluteus
maximus); aspiration is necessary to avoid inadvertent injection into a blood
vessel. Individual IM doses of 2 grams may be given if the dose is divided and
is administered in different intramuscular sites.
IV Administration: The IV route is
preferable for patients with bacteremia, bacterial septicemia, peritonitis,
meningitis, or other severe or life-threatening infections, or for patients who
may be poor risks because of lowered resistance resulting from such
debilitating conditions as malnutrition, trauma, surgery, diabetes, heart
failure, or malignancy, particularly if shock is present or impending.
For intermittent IV
administration, a solution containing 1 gram or 2 grams in 10 mL of Sterile
Water for Injection can be injected over a period of three to five minutes.
Cefotaxime should not be administered over a period of less than three minutes.
(See WARNINGS). With an infusion system, it may also be given over a
longer period of time through the tubing system by which the patient may be
receiving other IV solutions. However, during infusion of the solution
containing CLAFORAN, it is advisable to discontinue temporarily the
administration of other solutions at the same site.
For the administration of higher doses by continuous IV
infusion, a solution of CLAFORAN may be added to IV bottles containing the
solutions discussed below.
Directions for use of CLAFORAN Injection in Galaxy Container
(PL 2040 Plastic)
CLAFORAN Injection in Galaxy containers (PL 2040 plastic)
is for continuous or intermittent infusion using sterile equipment.
Store in a freezer capable of maintaining a temperature
Thawing of Plastic Container
Thaw frozen container at room temperature or under
refrigeration (at or below 5°C). [DO NOT FORCE THAW BY IMMERSION IN WATER BATHS
OR BY MICROWAVE IRRADIATION.]
Check for minute leaks by squeezing container firmly. If
leaks are detected, discard solution as sterility may be impaired.
DO NOT ADD SUPPLEMENTARY MEDICATION.
The container should be visually inspected. Components of
the solution may precipitate in the frozen state and will dissolve upon
reaching room temperature with little or no agitation. Potency is not affected.
Agitate after solution has reached room temperature. If after visual inspection
the solution remains cloudy or if an insoluble precipitate is noted or if any
seals or outlet ports are not intact, the container should be discarded.
The thawed solution is stable for 10 days under
refrigeration (at or below 5°C) or 24 hours at or below 22°C. Do not refreeze
CAUTION: Do not use plastic containers in series
connections. Such use could result in air embolism due to residual air being
drawn from the primary container before administration of the fluid from the
secondary container is complete.
Preparation for Intravenous Administration:
- Suspend container from eyelet support.
- Remove protector from outlet port at bottom of container.
- Attach administration set. Refer to complete directions
Preparation of CLAFORAN Sterile in ADD-Vantage System
CLAFORAN Sterile 1 g or 2 g may be reconstituted in 50 mL
or 100 mL of 5% Dextrose or 0.9% Sodium Chloride in the ADD-Vantage diluent
container. Refer to enclosed, separate INSTRUCTIONS FOR ADD-VANTAGE SYSTEM.
Compatibility and Stability
Solutions of CLAFORAN Sterile reconstituted as described
above (Preparation of CLAFORAN Sterile) remain chemically stable
(potency remains above 90%) as follows when stored in original containers and
disposable plastic syringes:
||Reconstituted Concentration mg/mL
||Stability at or below 22°C
||Stability under Refrigeration (at or below 5°C) Original Containers
|500 mg vial IM
|1g vial IM
|2g vial IM
|500 mg vial IV
|1g vial IV
|2g vial IV
|1g infusion bottle
|2g infusion bottle
Reconstituted solutions stored
in original containers and plastic syringes remain stable for 13 weeks frozen.
Reconstituted solutions may be
further diluted up to 1000 mL with the following solutions and maintain
satisfactory potency for 24 hours at or below 22°C, and at least 5 days under
refrigeration (at or below 5°C): 0.9% Sodium Chloride Injection; 5 or 10%
Dextrose Injection; 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose
and 0.45% Sodium Chloride Injection; 5% Dextrose and 0.2% Sodium Chloride
Injection; Lactated Ringer's Solution; Sodium Lactate Injection (M/6); 10%
Invert Sugar Injection, 8.5% TRAVASOL® (Amino Acid) Injection
Solutions of CLAFORAN Sterile
reconstituted in 0.9% Sodium Chloride Injection or 5% Dextrose Injection in
Viaflex® plastic containers maintain satisfactory potency for 24
hours at or below 22°C, 5 days under refrigeration (at or below 5°C) and 13
weeks frozen. Solutions of CLAFORAN Sterile reconstituted in 0.9% Sodium
Chloride Injection or 5% Dextrose Injection in the ADD-Vantage flexible
containers maintain satisfactory potency for 24 hours at or below 22°C. DO NOT
NOTE: CLAFORAN solutions
exhibit maximum stability in the pH 5-7 range. Solutions of CLAFORAN should not
be prepared with diluents having a pH above 7.5, such as Sodium Bicarbonate
Parenteral drug products should
be inspected visually for particulate matter and discoloration prior to
administration, whenever solution and container permit.
Sterile CLAFORAN is a dry off-white to pale yellow
crystalline powder supplied in vials and bottles containing cefotaxime sodium
500 mg cefotaxime (free acid equivalent) in vials in
packages of 10 (NDC 0039-0017-10).
1 g cefotaxime (free acid equivalent) in vials in
packages of 10 (NDC 0039-0018-10), packages of 25 (NDC 0039-0018-25), packages
of 50 (NDC 0039-0018-50); infusion bottles in packages of 10 (NDC
2 g cefotaxime (free acid equivalent) in vials in
packages of 10 (NDC 0039-0019-10), packages of 25 (NDC 0039-0019-25), packages
of 50 (NDC 0039-0019-50); infusion bottles in packages of 10 (NDC
1 g cefotaxime (free acid equivalent) in ADD-Vantage
System vials in packages of 25 (NDC 00390023-25) and 50 (NDC 0039-0023-50).
2 g cefotaxime (free acid equivalent) in ADD-Vantage
System vials in packages of 25 (NDC 00390024-25) and 50 (NDC 0039-0024-50).
ADD-Vantage System diluents (5% Dextrose or 0.9% Sodium
Chloride) are available from Abbott Laboratories.
Pharmacy Bulk Package:
10g cefotaxime (free acid equivalent) in bottles (NDC
NOTE: CLAFORAN in the dry state should be stored
below 30°C. The dry material as well as solutions tend to darken depending on
storage conditions and should be protected from elevated temperatures and
Premixed CLAFORAN Injection is supplied as a frozen,
iso-osmotic, sterile, nonpyrogenic solution in 50 mL single dose Galaxy
containers (PL 2040 plastic) as follows:
1 g cefotaxime (free acid equivalent) in packages of 12
(NDC 0039-0037-05) 2G3518.
2 g cefotaxime (free acid equivalent) in packages of 12
(NDC 0039-0038-05) 2G3519.
NOTE: Store Premixed CLAFORAN Injection at or
below -20°C/-4°F. [See DIRECTIONS FOR USE OF CLAFORAN (cefotaxime injection)
IN GALAXY CONTAINERS (PL 2040 PLASTIC)].
CLAFORAN Injection supplied as a frozen, iso-osmotic,
sterile, nonpyrogenic solution in Galaxy containers (PL 2040 plastic) is
manufactured for sanofi-aventis U.S. LLC by Baxter Healthcare Corporation.
Revised February 2014. Manufactured for: sanofi-aventis U.S. LLC Bridgewater, NJ
08807, Claforan Injection in Galaxy Containers: Manufactured by: Baxter Healthcare Corporation Deerfield,
IL 60015. Manufactured for: sanofi-aventis U.S. LLC Bridgewater, NJ